Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
Study NCT ID:
NCT02929966
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2016-10-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Palliative Care in Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-27', 'studyFirstSubmitDate': '2016-10-08', 'studyFirstSubmitQcDate': '2016-10-08', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical status and quality of life', 'timeFrame': '12 months', 'description': 'Maugeri Respiratory Questionnaire reduced form'}, {'measure': 'depression', 'timeFrame': '12 months', 'description': 'Center for Epidemiologic Studies Depression score (C-ESDs)'}, {'measure': 'dyspnea score', 'timeFrame': '12 months', 'description': 'Borg scale'}], 'secondaryOutcomes': [{'measure': 'survival', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Idiophatic Pulmonary Fibrosis']}, 'referencesModule': {'references': [{'pmid': '34969647', 'type': 'DERIVED', 'citation': 'Bassi I, Guerrieri A, Carpano M, Gardini A, Prediletto I, Polastri M, Curtis JR, Nava S. Feasibility and efficacy of a multidisciplinary palliative approach in patients with advanced interstitial lung disease. A pilot randomised controlled trial. Pulmonology. 2023 Dec;29 Suppl 4:S54-S62. doi: 10.1016/j.pulmoe.2021.11.004. Epub 2021 Dec 28.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will examine the effect of introducing palliative in patients with end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not deemed to be treated, on patient-reported outcomes and end-of-life care. The investigators will randomly assign patients who receive either early palliative care integrated with standard respiratory care or standard respiratory care alone.\n\nQuality of life and symptoms will assessed at baseline and at 12 weeks The primary outcome will be the change in the quality of life and symptoms at 12 months.', 'detailedDescription': 'Advanced fibrosing interstitial lung disease (ILD) is a group of often progressive and incurable conditions.\n\nThe most common form of ILD, idiopathic pulmonary fibrosis (IPF), is associated with poor survival, and high symptom burden and poor quality of life as the disease progresses.\n\nILD represents an increasing proportion of patients with chronic hypoxemic respiratory failure.\n\nDespite this poor prognosis, palliative care remains underused in patients with ILD. This may be due to under-recognition of the palliative care needs and symptom burden, or unfamiliarity and discomfort with palliative therapies.\n\nThough oncology has largely embraced earlier integration of palliative care, which has translated into improvements in end-of-life (EOL) care for patients with lung cancer,palliative and EOL care for non-malignant diseases are now gaining increased attention.\n\nIn pulmonary disease, this research has mainly focused on COPD and demonstrated a significant burden of unmet palliative care needs and lower quality of EOL care compared with patients with cancer. Similar attention is only beginning to be paid to ILD, but symptom burden and quality of EOL care in patients with ILD have yet to be quantified, and furthermore none has so far investigated the possible role of palliative care in these patients.\n\nThe investigators will examine with the present study the effect of introducing palliative in patients with end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not deemed to be treated, on patient-reported outcomes and end-of-life care. The investigators will randomly assign patients who receive either early palliative care integrated with standard respiratory care or standard respiratory care alone.\n\nQuality of life and symptoms will assessed at baseline and at 12 weeks The primary outcome will be the change in the quality of life and symptoms at 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of idiophatic pulmonary fibrosis\n* resting partial arterial oxygen pressure (PaO2) \\< 60 mmHg\n* Decline in Forced Vital Capacity (FVC) \\> 10% in the last 6 months\n* stage 3 according to the GAP index\n\nExclusion Criteria:\n\n* active treatment with antifibrotic drug\n* concomitant cancer'}, 'identificationModule': {'nctId': 'NCT02929966', 'acronym': 'PULFIP', 'briefTitle': 'Palliative Care in Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Effect of Palliative Care in Patients With End Stage Pulmonary Fibrosis: a Randomized Control Pilot Study', 'orgStudyIdInfo': {'id': '120/2016/O/Sper'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'standard respiratory care', 'description': 'The patients will receive the usual respiratory care that included both the "classical" treatments with antifibrotic drugs and oxygen therapy', 'interventionNames': ['Other: standard respiratory care']}, {'type': 'EXPERIMENTAL', 'label': 'standard respiratory care PLUS a palliative care program', 'description': 'The patients will receive the usual respiratory care that included both the "classical" treatments with antifibrotic drugs and oxygen therapy PLUS a palliative care program that includes paid to assessing physical and psychosocial symptoms', 'interventionNames': ['Other: palliative care program']}], 'interventions': [{'name': 'palliative care program', 'type': 'OTHER', 'description': 'The program includes psychological support, spiritual care and respiratory therapist support', 'armGroupLabels': ['standard respiratory care PLUS a palliative care program']}, {'name': 'standard respiratory care', 'type': 'OTHER', 'description': 'the usual standard pharmacological care plus oxygen therapy', 'armGroupLabels': ['standard respiratory care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Province', 'country': 'Italy', 'facility': "Sant'Orsola Malpighi Hospital", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': "San'Orsola Malpighi Hospital, Bologna ITALY", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Respiratory Medicine', 'investigatorFullName': 'dr. Stefano Nava', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}